CClinicalTrials.gg
CompletedNCT05427734Updated Apr 17, 2026Results posted

Drivers of Suicide Mobile App Study

An interventional study of WisePath for Adults and Active-Control app + electronic wellness resources brochure in Suicide, Suicide, Attempted and Suicidal Ideation, sponsored by Evidence-Based Practice Institute, Seattle, WA. Completed at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Evidence-Based Practice Institute, Seattle, WA · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study summary

The central purpose of this project is to evaluate and facilitate access to evidence-based best practices for individuals struggling with suicidal ideation and co-occurring behavioral problems, including alcohol misuse, and provide assistance to the patients while they are waiting to receive care, as they are receiving care, and after they return home. While WisePath is highly innovative in how it delivers these best practices, the content is well-established and known to reduce suicidality and alcohol misuse.

We will conduct a 12-week intent-to-treat RCT with 120 suicidal adults 22 years and older who may also be experiencing alcohol misuse. Participants will be randomly assigned to WisePath (n=60) or an active control condition (n=60) including a control suicide prevention self-help app plus an electronic wellness resources brochure containing links to health and wellness materials, psychoeducation about suicide, depression, self-help recovery-focused resources (e.g., Alcoholics Anonymous and other 12-Step programs, Moderation Management, etc.), and phone/text information for the 988 Suicide \& Crisis Lifeline. Participants will be assessed at baseline, 4, 8 and 12 weeks.

Read the detailed description

This study will test the newly developed WisePath for Adults ("WisePath"), a robust digital technology developed under NIAAA SBIR Fast-Track award (R44AA029868; Drs. Dimeff \& Jobes, Co-PIs) that is developed to efficiently and reliably aid delivery of recommended best-practices for the treatment of suicidal ideation in adults, including suicidal individuals who also misuse alcohol. WisePath includes techniques for prevention of suicidal behaviors (ideation, planning, attempts) while providing access to support resources in the moment via a mobile app. WisePath will include evidence-based practices for suicide prevention, including for those who are suicidal and also experience other behavioral health concerns such as depressed mood, sleep problems, and misuse of alcohol. This study will test WisePath with individuals who are experiencing these problems and recently sought treatment from a primary care provider. WisePath includes: psychoeducation, behavioral skills training, crisis stabilization planning, lethal means management, brief interventions for the treatment of suicidal ideation, depressed mood, sleep problems, alcohol misuse, and messages of hope, wisdom, and insights from people with lived experience (PLE).

We will conduct a randomized controlled trial (RCT; N=120) comparing WisePath (n=60) to an active control condition (a well-regarded suicide prevention self-help app + electronic wellness resources brochure; n=60) in adults experiencing suicidal ideation. To ensure a sufficient sample of individuals who misuse alcohol, no fewer than 35% (n=42) of the sample will be comprised of individuals who experience a harmful or hazardous level of alcohol use. Participants will be randomly assigned to a condition utilizing a minimization randomization procedure to match participants across condition on suicide severity, depression severity, and alcohol misuse. Participants will be assessed at baseline, 4, 8, and 12 weeks.

We hypothesize that in comparison to the active control condition, WisePath participants will show significantly better outcomes from baseline to the 4-, 8-, and 12-week assessment points such that:

  1. WisePath participants will report significantly greater decreases in suicidal and alcohol misuse behaviors compared to controls
  2. WisePath participants will report greater increases in self-efficacy and coping with suicidal thoughts and distress, as well as use of suicide prevention strategies compared to study controls
  3. WisePath participants will report a higher degree of satisfaction with their respective app compared to controls
02

Conditions studied

  • Suicide
  • Suicide, Attempted
  • Suicidal Ideation
  • Alcohol Use Disorder
  • Alcoholism
  • Alcohol Abuse
  • Screening and Brief Interventions
03

In context

Suicide

701 studies on the registry are indexed under Suicide; 183 are open to participants now.

This study's enrollment of 127 is above the median of 104 across 560 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

Evidence-Based Practice Institute, Seattle, WA is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Resides in the United States
  • 22+ years of age
  • English speaking
  • At risk for suicide, as evidenced by at least one of the following:
  • One or more lifetime suicide attempts (ASQ item 4)
  • Endorsement of any ASQ items 1 -3 (expanded from "past few weeks" in ASQ to "past 30 days" in our measures)

    • Item 1: In the past 30 days, have you wished you were dead?
    • Item 2: In the past 30 days, have you felt that you or your family would be better off if you were dead?
    • Item 3: In the 30 days, have you been having thoughts about killing yourself?
  • Currently has a primary care provider and sought care from them in the past year
  • Possesses and is the primary user of an Android- or iPhone-based smartphone with a data plan

Given that alcohol misuse exponentially increases the risk of death by suicide, can exacerbate other problems, and interfere with effective treatment, we will over-recruit individuals who misuse alcohol to ensure relevance of the tool for them. No fewer than 35% of the sample will be comprised of individuals who score 8 or more on the Alcohol Use Disorders Identification Test (AUDIT), indicating a harmful or hazardous level of drinking.

To ensure a sufficient sample of individuals who misuse alcohol, no fewer than 35% of the sample will be comprised of individuals who score 8 or more on the Alcohol Use Disorders Identification Test (AUDIT), indicating a harmful or hazardous level of drinking.

Exclusion criteria

Exclusion Criteria:

  • Severe depression (PHQ-9 score of 20 or greater)
  • Alcohol dependence (AUDIT score of 32 or greater)
  • Acutely suicidal (affirms item 5 of the Ask Suicide Screening Questions; Are you having thoughts of killing yourself right now? Followed by endorsing intent; Have you intended to act on urges to kill yourself in the past 30 days? or planning within the past 30 days; Have you made a plan to kill yourself in the past 30 days?)
  • Significant drug abuse problems (scores 6 or greater on the DAST-10)

Individuals who are excluded because of the severity of their depression, suicide acuity, and/or degree of substance use disorder will be provided with resources (i.e., the Suicide and Crisis Lifeline (988), SAMHSA's National Helpline) and encouraged to reach out to their primary care or mental/behavioral health provider.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    WisePath for Adults

    WisePath is designed to help support individuals during challenging moments and while experiencing behavioral concerns. The app is designed for people who struggle with depression, sleep problems, have feelings of wanting to die, or want to harm themselves, and/or misuse alcohol. WisePath includes specific tools for those who are experiencing suicidality, including creating a safety plan and teaching skills and strategies to get through distressing moments. You have been assigned to use the WisePath app while you are in this study.

    Device: WisePath for Adults

  • Active comparator
    Active-Control app + electronic wellness resources brochure

    Well-regarded suicide prevention self-help app, plus an electronic wellness resources brochure containing links to health and wellness materials, psychoeducation about suicide, depression, self-help recovery-focused resources (e.g., Alcoholics Anonymous, other 12-Step programs, Moderation Management, etc.), and phone/text information for the National Suicide Prevention Lifeline.

    Device: Active-Control app + electronic wellness resources brochure

Interventions

  • DeviceWisePath for Adults

    Participants assigned to this condition will receive access to the WisePath app for 12 weeks.

  • DeviceActive-Control app + electronic wellness resources brochure

    Participants assigned to this condition will receive access to Virtual Hope Box, a well-regarded suicide prevention self-help app, for 12 weeks plus an electronic wellness resources brochure.

06

What researchers measure

Primary outcomes

  1. Change in Self-Injurious Thoughts and Behaviors Interview-Revised

    A structured interview, which can also be delivered as a self-report measure, containing modules that assess suicidal ideation, suicide plans, suicide gestures, suicide attempts, and non-suicidal self injury. The SITBI has excellent psychometric properties, with inter-rater reliability coefficients in the range of 1.0 and strong test-retest reliability over six months. The SITBI correlates highly and in expected directions with other suicidal ideation measures and is behaviorally specific. Peak Suicidal Ideation Intensity, Suicide Plan Forecasting, and Suicide Attempt Forecasting are scored on a 5-point scale (0=Low/Little; 4=Very much/Severe). Higher scores indicate higher intensity of suicidal ideation and greater likelihood to make a suicide plan and attempt.

    Time frame: Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)

  2. Change in Self-Injurious Thoughts and Behaviors Interview-Revised

    A structured interview, which can also be delivered as a self-report measure, containing modules that assess suicidal ideation, suicide plans, suicide gestures, suicide attempts, and non-suicidal self injury. The SITBI has excellent psychometric properties, with inter-rater reliability coefficients in the range of 1.0 and strong test-retest reliability over six months. The SITBI correlates highly and in expected directions with other suicidal ideation measures and is behaviorally specific. Past 30-Day Suicidal Ideation Frequency refers to the number of times in the past month the behavior occurred. A higher number indicates a greater number of suicidal thoughts experienced in the last month.

    Time frame: Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)

  3. Change in Suicide-Related Coping Scale

    17-item, with 5 items scored in reverse, psychometrically-sound self-report measure of coping with suicidal thoughts, urges, and crises that uses a 5-point rating scale (0=strongly disagree; 4=strongly agree). There are two subscales, internal coping (minimum of 0 and maximum of 28) and external coping (minimum of 0 and maximum of 28). Subscale items are summed to generate total scores for each. Higher subscale scores indicate higher ability to cope with suicidality.

    Time frame: Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)

  4. Change in the Patient-Reported Outcome Measurement Information System (PROMIS)

    A well-validated, normed set of measures with standardized scoring. The measures of alcohol use (minimum of 0 and maximum of 28) and negative consequences related to alcohol use (minimum of 0 and maximum of 28) have 7 items. The measure of self-efficacy to manage emotions (minimum of 0 and maximum of 16) has 4 items. All measures are scored on a 5-point scale, (i.e., 0=never and 4=almost always for the alcohol use and negative consequences related to alcohol use measures; 0=I am not at all confident and 4=I am very confident for the self-efficacy to manage emotions measure), and responses are summed to create a raw total score for each measure. Higher scores for each measure indicate greater alcohol use, negative consequences related to alcohol use, and higher self-efficacy to manage emotions.

    Time frame: Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)

Secondary outcomes

  1. App Satisfaction Survey

    An eight-item survey used in EBPI's earlier research, which focuses on an app's ease of use and helpfulness. The initial six items use a five-point rating scale (1=poor; 5=excellent). Users also provide an overall satisfaction rating for their condition app using a 100-point scale (1=the worst; 100=the best) and indicate whether they would recommend using the app to others in their situation. The scores for the initial six items were also summed and averaged to generate the Average of Satisfaction Items score. Higher scores indicate the app has greater ease of use and helpfulness, and the respondent felt more cared about, supported, likely to recommend the app, and greater satisfaction with the app.

    Time frame: 12 weeks (time 4)

Other outcomes

  1. Alcohol Use Disorders Identification Test (AUDIT)

    A 10-item psychometrically sound self-report measure (minimum 0 and maximum 40) used to assess alcohol intake, potential dependence on alcohol, and experience of alcohol-related harm. Items 1-8 are scored on a 5-point scale (0=Never to 4=Daily or almost daily; 0=Never to 4=4 or more times a week; 0=1 or 2 to 4=10 or more). Items 9 and 10 are scored on a 3-point scale (0=No; 2=Yes, but not in the last year; 4=Yes, during the last year). Items are summed to generate a total score. A score of 0 suggests no experience with problems related to alcohol use; 1 to 7 suggests low-risk consumption; 8 to 14 suggest hazardous or harmful alcohol consumption; and 15 or more indicates the likelihood of alcohol dependence.

    Time frame: Eligibility Screen (Time 0)

  2. Drug Abuse Screening Test (DAST-10)

    A 10-item psychometrically validated self-administered screening tool (minimum of 0 and maximum of 10) for drug-related problems. Items are scored on a binary scale. (No=0; Yes=1), except for item 3 which is reverse scored. Items are summed to generate a total score. Higher scores indicate a greater degree of problems related to drug use.

    Time frame: Eligibility Screen (Time 0)

  3. Patient Health Questionnaire-9 (PHQ-9)

    The nine-item questionnaire assesses recent depressive symptoms, and has excellent sensitivity (.77 to .86) and specificity (.78 to .95) in detecting major depression. Scores of 1-9 indicate minimal to mild depression; 10-14, moderate depression; and 15-19, moderate to severe depression.

    Time frame: Eligibility Screen (Time 0)

07

Results

Posted Apr 17, 2026

Participant flow

Participants were recruited through primary care clinics and a third-party organization, User Interviews.

Participant flow — Overall Study
MilestoneWisePath for AdultsActive-Control App + Electronic Wellness Resources Brochure
Started6463
Completed6161
Not completed32

Outcome measures

PrimaryChange in Self-Injurious Thoughts and Behaviors Interview-Revised

A structured interview, which can also be delivered as a self-report measure, containing modules that assess suicidal ideation, suicide plans, suicide gestures, suicide attempts, and non-suicidal self injury. The SITBI has excellent psychometric properties, with inter-rater reliability coefficients in the range of 1.0 and strong test-retest reliability over six months. The SITBI correlates highly and in expected directions with other suicidal ideation measures and is behaviorally specific. Peak Suicidal Ideation Intensity, Suicide Plan Forecasting, and Suicide Attempt Forecasting are scored on a 5-point scale (0=Low/Little; 4=Very much/Severe). Higher scores indicate higher intensity of suicidal ideation and greater likelihood to make a suicide plan and attempt.

Time frame:
Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
Reported as:
Mean · Scores on a scale
Change in Self-Injurious Thoughts and Behaviors Interview-Revised
Scores on a scaleWisePath for AdultsActive-Control App + Electronic Wellness Resources Brochure
Suicide Plan Forecasting Time 10.92 ± 1.01.05 ± 1.0
Suicide Plan Forecasting Time 20.62 ± 0.90.74 ± 0.9
Suicide Plan Forecasting Time 30.66 ± 1.00.65 ± 0.9
Suicide Plan Forecasting Time 40.65 ± 1.00.48 ± 0.9
Suicide Attempt Forecasting Time 10.84 ± 0.90.78 ± 0.8
Suicide Attempt Forecasting Time 20.64 ± 0.90.52 ± 0.7
Suicide Attempt Forecasting Time 30.58 ± 1.00.40 ± 0.7
Suicide Attempt Forecasting Time 40.46 ± 0.80.32 ± 0.6
Peak Suicidal Ideation Intensity Time 11.98 ± 1.32.11 ± 1.7
Peak Suicidal Ideation Intensity Time 21.64 ± 1.51.10 ± 1.3
Peak Suicidal Ideation Intensity Time 31.25 ± 1.41.15 ± 1.4
Peak Suicidal Ideation Intensity Time 41.12 ± 1.41.13 ± 1.4
PrimaryChange in Self-Injurious Thoughts and Behaviors Interview-Revised

A structured interview, which can also be delivered as a self-report measure, containing modules that assess suicidal ideation, suicide plans, suicide gestures, suicide attempts, and non-suicidal self injury. The SITBI has excellent psychometric properties, with inter-rater reliability coefficients in the range of 1.0 and strong test-retest reliability over six months. The SITBI correlates highly and in expected directions with other suicidal ideation measures and is behaviorally specific. Past 30-Day Suicidal Ideation Frequency refers to the number of times in the past month the behavior occurred. A higher number indicates a greater number of suicidal thoughts experienced in the last month.

Time frame:
Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
Reported as:
Mean · Events
Change in Self-Injurious Thoughts and Behaviors Interview-Revised
EventsWisePath for AdultsActive-Control App + Electronic Wellness Resources Brochure
Past 30-Day Suicidal Ideation Frequency Time 14.98 ± 6.14.14 ± 6.4
Past 30-Day Suicidal Ideation Frequency Time 23.16 ± 5.72.58 ± 6.3
Past 30-Day Suicidal Ideation Frequency Time 32.13 ± 4.72.45 ± 6.4
Past 30-Day Suicidal Ideation Frequency Time 42.42 ± 5.71.49 ± 4.4
PrimaryChange in Suicide-Related Coping Scale

17-item, with 5 items scored in reverse, psychometrically-sound self-report measure of coping with suicidal thoughts, urges, and crises that uses a 5-point rating scale (0=strongly disagree; 4=strongly agree). There are two subscales, internal coping (minimum of 0 and maximum of 28) and external coping (minimum of 0 and maximum of 28). Subscale items are summed to generate total scores for each. Higher subscale scores indicate higher ability to cope with suicidality.

Time frame:
Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
Reported as:
Mean · Score on a scale
Change in Suicide-Related Coping Scale
Score on a scaleWisePath for AdultsActive-Control App + Electronic Wellness Resources Brochure
External Coping Time 119.16 ± 4.619.15 ± 5.2
External Coping Time 220.47 ± 4.920.29 ± 5.4
External Coping Time 321.49 ± 5.421.89 ± 4.6
External Coping Time 421.85 ± 5.122.15 ± 4.8
Internal Coping Time 120.29 ± 4.619.40 ± 5.3
Internal Coping Time 220.90 ± 5.121.47 ± 4.5
Internal Coping Time 321.98 ± 4.622.00 ± 4.8
Internal Coping Time 423.20 ± 4.522.41 ± 4.7
SecondaryApp Satisfaction Survey

An eight-item survey used in EBPI's earlier research, which focuses on an app's ease of use and helpfulness. The initial six items use a five-point rating scale (1=poor; 5=excellent). Users also provide an overall satisfaction rating for their condition app using a 100-point scale (1=the worst; 100=the best) and indicate whether they would recommend using the app to others in their situation. The scores for the initial six items were also summed and averaged to generate the Average of Satisfaction Items score. Higher scores indicate the app has greater ease of use and helpfulness, and the respondent felt more cared about, supported, likely to recommend the app, and greater satisfaction with the app.

Time frame:
12 weeks (time 4)
Reported as:
Mean · Score on a scale
App Satisfaction Survey
Score on a scaleWisePath for AdultsActive-Control App + Electronic Wellness Resources Brochure
Overall Satisfaction68.50 ± 23.5660.08 ± 26.58
Ease of Use3.75 ± 1.163.80 ± 0.91
Helpfulness3.07 ± 1.292.84 ± 1.25
Felt Cared About2.68 ± 1.302.26 ± 1.11
Received Help or Support2.87 ± 1.352.52 ± 1.32
Recommendation Likelihood2.87 ± 1.312.93 ± 1.42
Rating of Care3.35 ± 1.232.72 ± 1.17
Average of Satisfaction Items3.18 ± 1.112.85 ± 1.02
Other pre-specifiedAlcohol Use Disorders Identification Test (AUDIT)

A 10-item psychometrically sound self-report measure (minimum 0 and maximum 40) used to assess alcohol intake, potential dependence on alcohol, and experience of alcohol-related harm. Items 1-8 are scored on a 5-point scale (0=Never to 4=Daily or almost daily; 0=Never to 4=4 or more times a week; 0=1 or 2 to 4=10 or more). Items 9 and 10 are scored on a 3-point scale (0=No; 2=Yes, but not in the last year; 4=Yes, during the last year). Items are summed to generate a total score. A score of 0 suggests no experience with problems related to alcohol use; 1 to 7 suggests low-risk consumption; 8 to 14 suggest hazardous or harmful alcohol consumption; and 15 or more indicates the likelihood of alcohol dependence.

Time frame:
Eligibility Screen (Time 0)
Reported as:
Mean · Score on a scale
Alcohol Use Disorders Identification Test (AUDIT)
Score on a scaleWisePath for AdultsActive-Control App + Electronic Wellness Resources Brochure
Alcohol Use Disorders Identification Test (AUDIT)7.95 ± 7.87.08 ± 6.7
Other pre-specifiedDrug Abuse Screening Test (DAST-10)

A 10-item psychometrically validated self-administered screening tool (minimum of 0 and maximum of 10) for drug-related problems. Items are scored on a binary scale. (No=0; Yes=1), except for item 3 which is reverse scored. Items are summed to generate a total score. Higher scores indicate a greater degree of problems related to drug use.

Time frame:
Eligibility Screen (Time 0)
Reported as:
Mean · Score on a scale
Drug Abuse Screening Test (DAST-10)
Score on a scaleWisePath for AdultsActive-Control App + Electronic Wellness Resources Brochure
Drug Abuse Screening Test (DAST-10)1.31 ± 1.50.95 ± 1.2
Other pre-specifiedPatient Health Questionnaire-9 (PHQ-9)

The nine-item questionnaire assesses recent depressive symptoms, and has excellent sensitivity (.77 to .86) and specificity (.78 to .95) in detecting major depression. Scores of 1-9 indicate minimal to mild depression; 10-14, moderate depression; and 15-19, moderate to severe depression.

Time frame:
Eligibility Screen (Time 0)
Reported as:
Mean · Score on a scale
Patient Health Questionnaire-9 (PHQ-9)
Score on a scaleWisePath for AdultsActive-Control App + Electronic Wellness Resources Brochure
Patient Health Questionnaire-9 (PHQ-9)11.75 ± 5.111.46 ± 5.2
PrimaryChange in the Patient-Reported Outcome Measurement Information System (PROMIS)

A well-validated, normed set of measures with standardized scoring. The measures of alcohol use (minimum of 0 and maximum of 28) and negative consequences related to alcohol use (minimum of 0 and maximum of 28) have 7 items. The measure of self-efficacy to manage emotions (minimum of 0 and maximum of 16) has 4 items. All measures are scored on a 5-point scale, (i.e., 0=never and 4=almost always for the alcohol use and negative consequences related to alcohol use measures; 0=I am not at all confident and 4=I am very confident for the self-efficacy to manage emotions measure), and responses are summed to create a raw total score for each measure. Higher scores for each measure indicate greater alcohol use, negative consequences related to alcohol use, and higher self-efficacy to manage emotions.

Time frame:
Baseline (time 1), 4 weeks (time 2), 8 weeks (time 3), 12 weeks (time 4)
Reported as:
Mean · Score on a scale
Change in the Patient-Reported Outcome Measurement Information System (PROMIS)
Score on a scaleWisePath for AdultsActive-Control App + Electronic Wellness Resources Brochure
Alcohol Use Time 110.05 ± 8.89.86 ± 8.2
Alcohol Use Time 27.26 ± 7.87.24 ± 8.2
Alcohol Use Time 36.29 ± 7.15.45 ± 7.3
Alcohol Use Time 45.67 ± 6.85.61 ± 7.1
Negative Alcohol Use Consequences Time 18.11 ± 7.48.40 ± 7.0
Negative Alcohol Use Consequences Time 25.57 ± 5.75.85 ± 6.2
Negative Alcohol Use Consequences Time 34.80 ± 5.24.40 ± 5.6
Negative Alcohol Use Consequences Time 44.38 ± 5.04.41 ± 5.0
Emotion Self-Efficacy Time 111.97 ± 3.111.76 ± 3.4
Emotion Self-Efficacy Time 212.26 ± 3.113.31 ± 3.4
Emotion Self-Efficacy Time 312.86 ± 3.113.81 ± 3.3
Emotion Self-Efficacy Time 412.72 ± 3.214.21 ± 3.2

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
WisePath for Adults0/64 (0%)0/64 (0%)36/64 (56.3%)
Active-Control App + Electronic Wellness Resources Brochure0/63 (0%)0/63 (0%)35/63 (55.6%)
Most frequent serious events
Most frequent serious events
EventWisePath for AdultsActive-Control App + Electronic Wellness Resources Brochure
Suicide attempt that leads to acute hospital-based carePsychiatric disorders0/640/63
Alcohol poisoning that leads to acute hospital-based carePsychiatric disorders0/640/63
Most frequent other events
Most frequent other events
EventWisePath for AdultsActive-Control App + Electronic Wellness Resources Brochure
Significant increase in suicidal ideation frequencyPsychiatric disorders16/6414/63
Self-report of blackouts related to alcohol usePsychiatric disorders13/6410/63
Significant increase in alcohol usePsychiatric disorders9/6410/63
Significant increase in negative consequences related to alcohol usePsychiatric disorders9/648/63
Significant increase in suicidal ideation intensityPsychiatric disorders7/647/63
Self-report of injuries to themselves or others related to alcohol usePsychiatric disorders4/643/63
Warm Handoff to 988Psychiatric disorders3/641/63
Suicide attempts that do not require medical attention or hospital-based carePsychiatric disorders0/641/63
Suicide attempt that leads to acute hospital-based care (e.g., ED visit)Psychiatric disorders0/640/63

Baseline characteristics

All participants completed Baseline (Time 1).

Age, Categorical
Age, Categorical(Participants)WisePath for AdultsActive-Control App + Electronic Wellness Resources BrochureTotal
<=18 years000
Between 18 and 65 years6460124
>=65 years033
Sex/Gender, Customized
Sex/Gender, Customized(Participants)WisePath for AdultsActive-Control App + Electronic Wellness Resources BrochureTotal
Female343771
Male272552
Nonbinary314
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)WisePath for AdultsActive-Control App + Electronic Wellness Resources BrochureTotal
White323567
Black221941
Asian or Asian American9716
American Indian or Alaskan Native7411
Native Hawaiian or Other Pacific Islander202
Other6713
Region of Enrollment
Region of Enrollment(Participants)WisePath for AdultsActive-Control App + Electronic Wellness Resources BrochureTotal
United States6463127
Hispanic/Latinx
Hispanic/Latinx(Participants)WisePath for AdultsActive-Control App + Electronic Wellness Resources BrochureTotal
Hispanic/Latinx131326
Not Hispanic/Latinx5150101
Mental Health Treatment
Mental Health Treatment(Participants)WisePath for AdultsActive-Control App + Electronic Wellness Resources BrochureTotal
Not engaged in mental health treatment333366
2 or less hours a week302959
3 or more hours a week112
Employment
Employment(Participants)WisePath for AdultsActive-Control App + Electronic Wellness Resources BrochureTotal
Employed504696
Unemployed141731
Lifetime Suicide Attempts
Lifetime Suicide Attempts(Participants)WisePath for AdultsActive-Control App + Electronic Wellness Resources BrochureTotal
None403878
1-2101121
3 or more141428

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Evidence-Based Practice Institute, Inc.
    Seattle, Washington 98126, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 20, 2025
  • Informed consent form · Jan 22, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@jasprhealth.com. The final dataset will include self-reported demographic and behavioral data from participants in the randomized controlled trial. The dataset will include sensitive data from participants regarding suicidal behavior and substance use. Even though the final dataset will be stripped of identifiers prior to release for sharing, investigators believe that there remains the possibility of deductive disclosure of participants. Thus, the de-identified dataset will be distributed by Drs. Dimeff and Jobes to those that request it and only under a data-sharing agreement that includes: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate security protections; and (3) a commitment to destroying the data after analyses are completed.

Supporting information: Study protocol, Sap, Icf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05427734
Lead sponsor
Evidence-Based Practice Institute, Seattle, WA
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Sponsor
First posted
Jun 22, 2022
Start date
Mar 5, 2025
Primary completion
Nov 10, 2025
Completion
Nov 10, 2025
Results posted
Apr 17, 2026
Last update
Apr 17, 2026

Study contacts

Linda A. Dimeff, PhD
principal investigator · Chief Executive Officer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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